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Completed

NCT Number: NCT05035654

LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)

This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.

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Key information

Conditions

Chronic Sinusitis Chronic Rhinosinusitis (Diagnosis) Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lyra Investigational Site, Bedford Park, Australia

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About this study

This is a Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220. The study will consist of two parts: Part 1 will enroll up to 10 patients and is open label. Part 2 is randomized, sham controlled and will enroll approximately 40 patients. The study follow-up duration is 28 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of chronic rhinosinusitis.
  • Has had a prior bilateral total ethmoidectomy.
  • Has computed tomography (CT) ethmoid cavity opacification.
  • Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit.
  • Minimum cardinal symptom score.
  • Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory authority if applicable by national law.
  • Agrees to comply with all study requirements.

Exclusion criteria

  • Pregnant or breast feeding.
  • Known history of hypersensitivity or intolerance to corticosteroids.
  • History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
  • Known history of hypothalamic pituitary adrenal axial dysfunction.
  • Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
  • Past or present functional vision in only one eye.
  • Past, present, or planned organ transplant or chemotherapy with immunosuppression.
  • With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter.
  • Ethmoidectomy that was unilateral or partial.
  • Currently participating in an investigational drug or device study.

Treatment and study plan

LYR-220 Design 1 (Part 1 only)

Drug

LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1

LYR-220 Design 2 (Part 1 and Part 2)

Drug

LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2

Bilateral sham procedure control (Part 2)

Drug

Bilateral sham procedure control

Primary outcomes

  1. Product-related Unexpected Serious Adverse Events

    Time frame: Through Week 28

    Product-related unexpected serious adverse events

  2. Plasma MF Concentrations

    Time frame: Through Week 25

    Plasma MF concentrations at 1 hour post study treatment administration and at Days 2 or 3, days 5 or 8, and Weeks 4,12,16 or 20, 24 and 25.

    The PK analysis will be performed based on subjects with available plasma MF concentration data post Day 1 administration procedure.

Secondary outcomes

  1. Adverse Events

    Time frame: Through Week 28

    Percentage of subjects reporting treatment-emergent adverse events

  2. Endoscopic Findings

    Time frame: Through Week 25

    Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)

  3. Ophthalmic Assessment: Intraocular Pressure (IOP)

    Time frame: Through Week 25

    Percentage of subjects with clinically significant increase in IOP

  4. Ophthalmic Assessment: Cataract

    Time frame: Through Week 25

    Percentage of subjects with newly identified or worsened cataract in one or both eyes

  5. Improving Chronic Rhinosinusitis (CRS) Specific Quality of Life as Per the 22-item Sino-nasal Outcome Test (SNOT-22) Questionnaire

    Time frame: Through Week 28

    The 22-item Sino-Nasal Outcome Test (SNOT-22) questionnaire is a 22-item disease-specific quality of life instrument validated for use in CRS. Each symptom is scored as it has been over the past 2 weeks on a 6-point scale as follows: 0 = no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be.

    The outcome measure is change from baseline in total patient-reported outcome score. The SNOT-22 total score is the sum of individual scores and ranges from 0 to 110. Higher scores indicate higher severity of symptoms.

  6. Change From Baseline in the Average Composite Score Over the Preceeding 7 Days of the 3 Cardinal Symptoms (3CS)

    Time frame: Through Week 28

    Change from baseline in the average composite score over the preceeding 7 days of the 3 Cardinal Symptoms (3CS).The 3CS include: nasal blockage/obstruction/congestion, facial pain/ pressure, and anterior/posterior nasal discharge. The diary is completed daily by study participants throughout the study. Each symptom/each question is scored daily on a 0-3 scale as follows: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

Sponsors and collaborators

Lead sponsor

Lyra Therapeutics

Industry

Registry information

Official study title

BEACON: A Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220 in Chronic Rhinosinusitis (CRS) Patients Who Have Had a Prior Ethmoidectomy

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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